These days, your medical devices could be in for quite an adventure. “Medical device supply chains are getting more rigorous by the year,” says Sarah Rosenblum, director of business development and marketing at Packaging Compliance Labs. “With the development of new shipping methods, that leaves a lot of people scratching their heads wondering how to test it.”

For instance, “the hottest topic in this subject matter has been drone shipping,” she says. “While this is still some time away from being implemented, there are many elements to consider while shipping from a drone.

But even if you’re not ready for drone shipping, the typical rigors of medical device sterilization and transportation are presenting new risks and considerations. These hazards include extreme climates, drop, shock, altitude, stacking, and vibration, explains Ryan Erickson, vice president and packaging engineer, Packaging Compliance Labs. He notes the following trends:

Globalization in medical manufacturing. This involves international shipping, ocean and rail freight, multiple distribution legs, multiple distribution configurations, warehouse and vehicle stacking, and exposures to a wider array of climates, modes of transport, and shipping durations throughout distribution.

An industry shift away from autoclave in favor of sterile products. Many instruments formerly shipped in metal cases (non-sterile) for autoclaving at the hospital are now moving to sterile disposable packaging, leading to significant changes in supply chain, distribution channels, and cost pressures.

Just-in-time order fulfillment. Production and transportation of nonstandard quantities and configurations are in demand.

Returnable procurement programs. Allowances for hospitals to return unused products leads to the same products being exposed to multiple rounds of shipping.

Sustainability. This often involves reductions in size and materials while still achieving design and performance requirements.

“Kevin and I will be 'looking inside the box' to observe the behavior of flexible and rigid packaging when subjected to the stresses of shock, vibration, and drop testing. We will discuss the dynamic forces at play and the potential effects of those forces on typical modes of failure – cracks, punctures, tears, and abrasion. The discussion will also review best practices for packaging design to mitigate risk and improve transportation testing outcomes,” Erickson says.

Packaging failure is typically associated with a design that isn’t rigorous enough to handle the device it contains, Rosenblum says. “This is often due to poor package design, large or heavy devices, failure to secure the device within the packaging, and more,” she says. “Packaging helps as the cushion to shield the device from the outside elements. It absorbs the delivery drivers’ kicks and tosses. It protects from that steamy hot truck driving around Miami. The packaging is the guardian for sterile medical devices and it must perform to prevent injury and ingress to the device.”

Erickson blames sterile barrier integrity failure to either “the dynamic forces of shock/vibration in transit or long-term degradation while on the shelf.” Such failures include:

Premature seal creep/seal channels.

Cracks, crushing, denting.

Punctures.

Tears.

Abrasion.

Rosenblum says that “as with any transportation test, you want to strain the package to its worst-case scenario in the shipping environment. That means applying the hottest/coldest temperatures and humidity on the package, dropping it from various heights, vibrating it like it would experience on the truck or airplane, and much more.”

She adds that “single-parcel shipments are undergoing the same scrutiny, although methods are currently developed to address that particular environment. For example, ISTA 6 is a standard that has been specifically developed for Amazon single parcel shipments.”

Test methods are always adapting to fit new environmental conditions and market changes, Rosenblum says. Adds Erickson: “Consensus standards are continuously evolving and changing to meet the needs of industry. Most notably, there was a new revision of ASTM D4169 in 2016 that affected the truck vibration simulation to align with updated data from the field; there are on-going changes to various climate conditioning procedures to address different exposure durations occurring in overnight shipments versus ground shipments.”